BIO 79-ACL4-2020

GUDID D78879ACL420200

BIO CU FORM A 20X20 L2 T2

Gc Orthodontics America Inc.

Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire
Primary Device IDD78879ACL420200
NIH Device Record Keyd3daac46-81e3-4819-8844-74c61b7d5cf5
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIO
Version Model Number79-ACL4-2020
Catalog Number79-ACL4-2020
Company DUNS063167128
Company NameGc Orthodontics America Inc.
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD78879ACL420200 [Unit of Use]
HIBCCD78879ACL420200 [Unit of Use]
HIBCCD78879ACL420200 [Unit of Use]
HIBCCD78879ACL420200 [Unit of Use]
HIBCCD78879ACL420200 [Unit of Use]
HIBCCD78879ACL420200 [Unit of Use]
HIBCCD78879ACL420200 [Unit of Use]
HIBCCD78879ACL420200 [Unit of Use]
HIBCCD78879ACL420200 [Unit of Use]
HIBCCD78879ACL420200 [Unit of Use]
HIBCCD78879ACL420200 [Unit of Use]
HIBCCD78879ACL420200 [Unit of Use]
HIBCCD78879ACL420200 [Unit of Use]
HIBCCD78879ACL420200 [Unit of Use]
HIBCCD78879ACL420201 [Primary]
HIBCCD78879ACL420201 [Primary]
HIBCCD78879ACL420201 [Primary]
HIBCCD78879ACL420201 [Primary]
HIBCCD78879ACL420201 [Primary]
HIBCCD78879ACL420201 [Primary]
HIBCCD78879ACL420201 [Primary]
HIBCCD78879ACL420201 [Primary]
HIBCCD78879ACL420201 [Primary]
HIBCCD78879ACL420201 [Primary]
HIBCCD78879ACL420201 [Primary]
HIBCCD78879ACL420201 [Primary]
HIBCCD78879ACL420201 [Primary]
HIBCCD78879ACL420201 [Primary]

FDA Product Code

DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-16
Device Publish Date2020-09-08

Devices Manufactured by Gc Orthodontics America Inc.

D788111D0300201 - EXPERIENCE®2020-09-16 EXP C 018 MBT U 4-4 HK 3
D78811202CC300301 - EXPERIENCE®2020-09-16 EXP CER U 5-5 L3-3 EXM L 45 HK 3
D78812192CC500201 - EXPERIENCE®2020-09-16 EXPC /RH MBT 022/UL 5-5 3,4,5 HK
D788122C0500201 - EXPERIENCE®2020-09-16 EXPM MBT 022 U 5-5 HK 3,4,5
D788122CE500201 - EXPERIENCE®2020-09-16 EXP C M MBT 022 U5-5 L3-3 HK 3,4,5
D788122EE300201 - EXPERIENCE®2020-09-16 EXCM MBT 022 U/L 3-3 HK3
D78814113D00210 - CHIC2020-09-16 CHIC MBT 018R U3/HK (OPT)
D78814123D00210 - CHIC2020-09-16 CHIC MBT 018L U3/HK (OPT)

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